FDA Teleconference Monday, May 23rd
I know many of you have questions about both these medications. I think if you take 50+ minutes and listen to the replay of the teleconference you will find most of your answers. It will only be available for 30 days so please take advantage of this opportunity. To hear the replay, callers can dial 888-324-7513.
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
Dear Colleague,
The Food and Drug Administration (FDA) invites you to participate in a teleconference briefing to discuss two Direct Acting Antivirals (DAAs) for the treatment of hepatitis C, boceprevir and telaprevir, that were discussed at an April 27 -28, 2011 meeting of the FDA Antiviral Drugs Advisory Committee. DAAs represent a significant addition to the treatment approach for many patients. However, the dosing regimens may be complex, and there are treatment issues about which health care providers and patients should be aware.
The teleconference will be held on Monday, May 23, 2011 from 3:30 PM to 4:30 PM EDT.
Following a brief introduction by Margaret Hamburg, Commissioner of the Food and Drug Administration, the briefing will provide an overview of the clinical trials, primary efficacy, safety, and complexity of dosing regimens. The briefing will consist of presentations by Debra Birnkrant, M.D, Director, and Jeffery Murray, Deputy Director, Division of Antiviral Products, Center for Drug Evaluation and Research (CDER), followed by an opportunity for questions from call participants. The briefing will be moderated by Richard Klein, FDA Office of Special Health Issues.
A replay will be available for 30 days, beginning approximately one hour after the briefing call ends. To hear the replay, callers can dial 888-324-7513.
Monday, May 23, 2011
FDA OKs Telaprevir for Hep C
FDA OKs Telaprevir for Hep C
WASHINGTON -- The FDA has approved telaprevir (Incivek) for treatment of hepatitis C genotype 1, making it the second new protease inhibitor to win agency approval for the condition this month.
Hepatitis C affects some three to four million people in the U.S.; about two-thirds have genotype 1.
The approval was all but certain after an FDA advisory committee unanimously endorsed telaprevir, made by Vertex Pharmaceuticals, in April. On May 13, the agency announced it is approving Merck's boceprevir (Victrelis).
Telaprevir and boceprevir work by targeting the virus directly; the current standard treatment regimen of pegylated interferon and ribavirin works instead by boosting patients' immune responses.
Both telaprevir and boceprevir are indicated as add-on treatment to pegylated interferon and ribavirin.
Telaprevir comes in pill form and is taken three times a day for 12 weeks, with peginterferon and ribavirin at standard doses for 24 or 48 weeks, depending on virologic response.
Adding a protease inhibitor to peginterferon and ribavirin is expected to become the new standard of care for HCV genotype 1 patients.
About half of patients treated with the standard peginterferon and ribavirin combo achieve sustained viral responses. The telaprevir trials indicated that adding the protease inhibitor could boost the sustained response rate above 70%, to as much as 90%, in patients who had never been treated for HCV, according to results from one study.
"With the approval of Incivek, there are now two important new treatment options for hepatitis C that offer a greater chance at a cure for some patients with this serious condition," said Edward Cox, MD, MPH, director of the FDA's Office of Antimicrobial Products.
"The availability of new therapies that significantly increase responses while potentially decreasing the overall duration of treatment is a major step forward in the battle against chronic hepatitis C infection," Cox said.
The FDA advisory panel that reviewed telaprevir was extremely confident that the drug works but was concerned about an increased incidence of serious and life-threatening skin reactions, including three cases of Stevens-Johnson syndrome in patients who took telaprevir.
More than half of patients receiving the drug reported rash or pruritus, with 6% discontinuing treatment as a result. These rates were about double those in the control groups.
Vertex assured the panel that those side effects are generally manageable and resolve after the drug is stopped.
http://www.medpagetoday.com/InfectiousDisease/GeneralInfectiousDisease/26638
~~~~~~~~~~~~~~~~~~~~~~~~~~~~
Telaprevir Patient Assistance Program
Helping People with Hepatitis C Get INCIVEK
The people who work at Vertex understand that medicines can only help patients who can get them. With that in mind, the company today introduced a comprehensive financial assistance and patient support program to help people get INCIVEK who might not otherwise be able to afford it. The program will help people with hepatitis C learn about insurance benefits for their medicines, give INCIVEK for free to eligible patients who do not have insurance and provide coverage for co-pay or co-insurance costs associated with INCIVEK for people who meet certain program criteria.
Additionally, patients will have access to nurses through a 24-7 hotline by which they can receive support, guidance and educational materials about hepatitis C and its treatment. Vertex will also provide nurses and doctors with educational tools and resources so they can offer support and care to people with hepatitis C before, during and after the treatment process.
For eligible patients, the program includes the following:
Insurance Benefits Research and Support: Vertex case managers will research patients' insurance benefits for INCIVEK combination treatment, assist people with insurance appeals and help guide them to other forms of financial support, including Vertex's free medicine and co-pay programs;
Free Medicine Program: Vertex will give INCIVEK for free to people who do not have insurance and have an annual household income of $100,000 or less; and
Co-Pay Support: Vertex will cover co-pay or co-insurance costs up to 20 percent of the total cost of INCIVEK for people who have private insurance plans that cover INCIVEK, regardless of their household income. For people covered by government insurance, Vertex will also make donations to the independent, non-profit Patient Access Network Foundation, which has a fund to provide co-pay support to people taking hepatitis C medicines.
More information about this program is available by calling 1-855-837-8394 or visiting www.INCIVEK.com
WASHINGTON -- The FDA has approved telaprevir (Incivek) for treatment of hepatitis C genotype 1, making it the second new protease inhibitor to win agency approval for the condition this month.
Hepatitis C affects some three to four million people in the U.S.; about two-thirds have genotype 1.
The approval was all but certain after an FDA advisory committee unanimously endorsed telaprevir, made by Vertex Pharmaceuticals, in April. On May 13, the agency announced it is approving Merck's boceprevir (Victrelis).
Telaprevir and boceprevir work by targeting the virus directly; the current standard treatment regimen of pegylated interferon and ribavirin works instead by boosting patients' immune responses.
Both telaprevir and boceprevir are indicated as add-on treatment to pegylated interferon and ribavirin.
Telaprevir comes in pill form and is taken three times a day for 12 weeks, with peginterferon and ribavirin at standard doses for 24 or 48 weeks, depending on virologic response.
Adding a protease inhibitor to peginterferon and ribavirin is expected to become the new standard of care for HCV genotype 1 patients.
About half of patients treated with the standard peginterferon and ribavirin combo achieve sustained viral responses. The telaprevir trials indicated that adding the protease inhibitor could boost the sustained response rate above 70%, to as much as 90%, in patients who had never been treated for HCV, according to results from one study.
"With the approval of Incivek, there are now two important new treatment options for hepatitis C that offer a greater chance at a cure for some patients with this serious condition," said Edward Cox, MD, MPH, director of the FDA's Office of Antimicrobial Products.
"The availability of new therapies that significantly increase responses while potentially decreasing the overall duration of treatment is a major step forward in the battle against chronic hepatitis C infection," Cox said.
The FDA advisory panel that reviewed telaprevir was extremely confident that the drug works but was concerned about an increased incidence of serious and life-threatening skin reactions, including three cases of Stevens-Johnson syndrome in patients who took telaprevir.
More than half of patients receiving the drug reported rash or pruritus, with 6% discontinuing treatment as a result. These rates were about double those in the control groups.
Vertex assured the panel that those side effects are generally manageable and resolve after the drug is stopped.
http://www.medpagetoday.com/InfectiousDisease/GeneralInfectiousDisease/26638
~~~~~~~~~~~~~~~~~~~~~~~~~~~~
Telaprevir Patient Assistance Program
Helping People with Hepatitis C Get INCIVEK
The people who work at Vertex understand that medicines can only help patients who can get them. With that in mind, the company today introduced a comprehensive financial assistance and patient support program to help people get INCIVEK who might not otherwise be able to afford it. The program will help people with hepatitis C learn about insurance benefits for their medicines, give INCIVEK for free to eligible patients who do not have insurance and provide coverage for co-pay or co-insurance costs associated with INCIVEK for people who meet certain program criteria.
Additionally, patients will have access to nurses through a 24-7 hotline by which they can receive support, guidance and educational materials about hepatitis C and its treatment. Vertex will also provide nurses and doctors with educational tools and resources so they can offer support and care to people with hepatitis C before, during and after the treatment process.
For eligible patients, the program includes the following:
Insurance Benefits Research and Support: Vertex case managers will research patients' insurance benefits for INCIVEK combination treatment, assist people with insurance appeals and help guide them to other forms of financial support, including Vertex's free medicine and co-pay programs;
Free Medicine Program: Vertex will give INCIVEK for free to people who do not have insurance and have an annual household income of $100,000 or less; and
Co-Pay Support: Vertex will cover co-pay or co-insurance costs up to 20 percent of the total cost of INCIVEK for people who have private insurance plans that cover INCIVEK, regardless of their household income. For people covered by government insurance, Vertex will also make donations to the independent, non-profit Patient Access Network Foundation, which has a fund to provide co-pay support to people taking hepatitis C medicines.
More information about this program is available by calling 1-855-837-8394 or visiting www.INCIVEK.com
Friday, May 13, 2011
Boceprevir Wins FDA Approval to Treat Hepatitis C
By Emily P. Walker, Washington Correspondent, MedPage Today
Published: May 13, 2011
WASHINGTON -- The FDA has approved the investigational drug boceprevir (Victrelis), to be used in combination with peginterferon and ribavirin, to treat hepatitis C genotype 1.
Boceprevir, made by Merck, will be the first HCV protease inhibitor to reach market and is expected to be a major advance in treating the disease, which affects between three and four million people in U.S.
"Victrelis is an important new advance for patients with hepatitis C," said Edward Cox, MD, MPH, director of antimicrobial products at the FDA in a press release. "This new medication provides an effective treatment for a serious disease, and offers a greater chance of cure for some patients' hepatitis C infection compared to currently available therapy."
The move was expected after a committee of outside experts voted unanimously in April that the FDA should approve the drug.
The panelists all agreed that boceprevir seems to be a safe and effective new option to treat HCV.
The approval was based on Merck's clinical trials, which showed that, in the difficult-to-treat genotype 1 patients, boceprevir yielded sustained virological response rates as high as 67%.
In contrast, the rate for patients getting the standard regimen of pegylated interferon injections and ribavirin pills was about 40%.
Until now, treatment has relied on boosting the immune system rather than attacking the virus directly.
One panelist at the April meeting marveled at how far HCV treatment has come in the past several decades and said achieving a 60% or 70% sustained response "seems like a dream come true."
The drug carries a number of hematologic side effects, including anemia, neutropenia, and thrombocytopenia. But the advisory committee members said the anemia is a manageable side effect during treatment and is reversible after the drug has been stopped.
The FDA is widely expected to approve another protease inhibitor for HCV, telaprevir, made by Vertex Pharmaceuticals. The same panel that endorsed boceprevir also voted unanimously that telaprevir be approved for the same indication.
Merck said it planned to begin shipping the drug next week.
Eliav Barr, MD, vice president of infectious diseases for Merck, told MedPage Today that about 70% of the estimated four million HCV patients in the U.S. will be candidates for treatment with the drug.
He cautioned that patients must, however, undergo four weeks of peginterferon/ribavirin treatment before initiating boceprevir.
http://www.medpagetoday.com/InfectiousDisease/Hepatitis/26469?utm_source=breaking-news&utm_medium=email&utm_campaign=breaking-news
By Emily P. Walker, Washington Correspondent, MedPage Today
Published: May 13, 2011
WASHINGTON -- The FDA has approved the investigational drug boceprevir (Victrelis), to be used in combination with peginterferon and ribavirin, to treat hepatitis C genotype 1.
Boceprevir, made by Merck, will be the first HCV protease inhibitor to reach market and is expected to be a major advance in treating the disease, which affects between three and four million people in U.S.
"Victrelis is an important new advance for patients with hepatitis C," said Edward Cox, MD, MPH, director of antimicrobial products at the FDA in a press release. "This new medication provides an effective treatment for a serious disease, and offers a greater chance of cure for some patients' hepatitis C infection compared to currently available therapy."
The move was expected after a committee of outside experts voted unanimously in April that the FDA should approve the drug.
The panelists all agreed that boceprevir seems to be a safe and effective new option to treat HCV.
The approval was based on Merck's clinical trials, which showed that, in the difficult-to-treat genotype 1 patients, boceprevir yielded sustained virological response rates as high as 67%.
In contrast, the rate for patients getting the standard regimen of pegylated interferon injections and ribavirin pills was about 40%.
Until now, treatment has relied on boosting the immune system rather than attacking the virus directly.
One panelist at the April meeting marveled at how far HCV treatment has come in the past several decades and said achieving a 60% or 70% sustained response "seems like a dream come true."
The drug carries a number of hematologic side effects, including anemia, neutropenia, and thrombocytopenia. But the advisory committee members said the anemia is a manageable side effect during treatment and is reversible after the drug has been stopped.
The FDA is widely expected to approve another protease inhibitor for HCV, telaprevir, made by Vertex Pharmaceuticals. The same panel that endorsed boceprevir also voted unanimously that telaprevir be approved for the same indication.
Merck said it planned to begin shipping the drug next week.
Eliav Barr, MD, vice president of infectious diseases for Merck, told MedPage Today that about 70% of the estimated four million HCV patients in the U.S. will be candidates for treatment with the drug.
He cautioned that patients must, however, undergo four weeks of peginterferon/ribavirin treatment before initiating boceprevir.
http://www.medpagetoday.com/InfectiousDisease/Hepatitis/26469?utm_source=breaking-news&utm_medium=email&utm_campaign=breaking-news
NVHR Commends New HHS Plan for the Prevention and Treatment of Viral Hepatitis
Press Release - NVHR Commends New HHS Plan for the Prevention and Treatment of Viral Hepatitis
May 12, 2011
Contact: Martha Saly
707.480.0596 – mbsaly@nvhr.org
NVHR Commends New HHS Plan for the Prevention and Treatment of Viral Hepatitis
A new Department of Health and Human Services (HHS) action plan for viral hepatitis takes the much needed step of establishing a roadmap to help improve response to this growing health problem. The HHS Action Plan for the Prevention and Treatment of Viral Hepatitis, released today by Assistant Secretary for Health Dr. Howard Koh, follows a 2010 Institute of Medicine (IOM) report, Hepatitis and Liver Cancer: A National Strategy for Prevention and Control of Hepatitis B and C. The IOM report found a troubling lack of knowledge about the devastating impact of this disease among health care and social services providers, at-risk populations, the general public and policymakers. The IOM report was commissioned in part by the National Viral Hepatitis Roundtable (NVHR).
“The release of the HHS Action Plan offers a tremendous opportunity to change the course of the viral hepatitis epidemic in the U.S.,” said Martha Saly , Director of the National Viral Hepatitis Roundtable (NVHR), “However, this plan will only be effective if the Administration strongly supports its implementation and Congress demonstrates leadership by increasing resources for prevention, education, care and treatment services for Americans, especially vulnerable and underserved populations, who are most at risk for viral hepatitis infections and their consequences.”
The CDC estimates that, 65% of people infected with hepatitis B and 75% of people infected with hepatitis C do not know that they have the disease, yet 1 in 12 Asian/Pacific Islander Americans is living with hepatitis B and African Americans are twice as likely to be infected with hepatitis C as the general population.
“With limited funds available for viral hepatitis, our nation does a poor job of screening and early intervention,” Saly said, noting that “most infected individuals only become aware of their condition after it has progressed to cirrhosis, liver failure, or liver cancer. That is not only a tragedy for those afflicted, but it also winds up costing much more money for our health care system.”
NVHR has prioritized viral hepatitis and liver cancer screening, along with tackling health disparities and barriers to care among Asian Americans, African Americans and other disproportionately affected populations; strengthening prevention efforts to confront a new wave of infections do to heroin use; and improving viral hepatitis services at community health centers as areas where the Federal Government can make an immediate impact on the burden of viral hepatitis in the United States.
NVHR is a coalition of more than 170 public, private and voluntary organizations dedicated to reducing the incidence of infection, morbidity and mortality from viral hepatitis in the United States. www.nvhr.org
COMBATING THE SILENT EPIDEMIC of VIRAL HEPATITIS
Action Plan for the Prevention, Care & Treatment of Viral Hepatitis
Just click on this link:
http://nvhr.org/sites/default/files/Viral-Hepatitis-Action-plan-2011.pdf
You can also find the link on the NVHR Home page at:
www.nvhr.org
May 12, 2011
Contact: Martha Saly
707.480.0596 – mbsaly@nvhr.org
NVHR Commends New HHS Plan for the Prevention and Treatment of Viral Hepatitis
A new Department of Health and Human Services (HHS) action plan for viral hepatitis takes the much needed step of establishing a roadmap to help improve response to this growing health problem. The HHS Action Plan for the Prevention and Treatment of Viral Hepatitis, released today by Assistant Secretary for Health Dr. Howard Koh, follows a 2010 Institute of Medicine (IOM) report, Hepatitis and Liver Cancer: A National Strategy for Prevention and Control of Hepatitis B and C. The IOM report found a troubling lack of knowledge about the devastating impact of this disease among health care and social services providers, at-risk populations, the general public and policymakers. The IOM report was commissioned in part by the National Viral Hepatitis Roundtable (NVHR).
“The release of the HHS Action Plan offers a tremendous opportunity to change the course of the viral hepatitis epidemic in the U.S.,” said Martha Saly , Director of the National Viral Hepatitis Roundtable (NVHR), “However, this plan will only be effective if the Administration strongly supports its implementation and Congress demonstrates leadership by increasing resources for prevention, education, care and treatment services for Americans, especially vulnerable and underserved populations, who are most at risk for viral hepatitis infections and their consequences.”
The CDC estimates that, 65% of people infected with hepatitis B and 75% of people infected with hepatitis C do not know that they have the disease, yet 1 in 12 Asian/Pacific Islander Americans is living with hepatitis B and African Americans are twice as likely to be infected with hepatitis C as the general population.
“With limited funds available for viral hepatitis, our nation does a poor job of screening and early intervention,” Saly said, noting that “most infected individuals only become aware of their condition after it has progressed to cirrhosis, liver failure, or liver cancer. That is not only a tragedy for those afflicted, but it also winds up costing much more money for our health care system.”
NVHR has prioritized viral hepatitis and liver cancer screening, along with tackling health disparities and barriers to care among Asian Americans, African Americans and other disproportionately affected populations; strengthening prevention efforts to confront a new wave of infections do to heroin use; and improving viral hepatitis services at community health centers as areas where the Federal Government can make an immediate impact on the burden of viral hepatitis in the United States.
NVHR is a coalition of more than 170 public, private and voluntary organizations dedicated to reducing the incidence of infection, morbidity and mortality from viral hepatitis in the United States. www.nvhr.org
COMBATING THE SILENT EPIDEMIC of VIRAL HEPATITIS
Action Plan for the Prevention, Care & Treatment of Viral Hepatitis
Just click on this link:
http://nvhr.org/sites/default/files/Viral-Hepatitis-Action-plan-2011.pdf
You can also find the link on the NVHR Home page at:
www.nvhr.org
Wednesday, May 11, 2011
May 12th Webinar for the Viral Hepatitis Action Plan!!!!
Each May, the Centers for Disease Control and Prevention (CDC) and its U.S. public health partners observe Hepatitis Awareness Month. Viral hepatitis affects an estimated 4.4 million people in the United States. To further increase awareness and improve the health outcomes of Americans, Health and Human Services Assistant Secretary for Health, Dr. Howard K. Koh, will release the report, Combating the Silent Epidemic: the U.S. Department of Health and Human Services Action Plan for the Prevention and Treatment of Viral Hepatitis on Thursday, May 12, from 1:00 to 2:00 p.m. ET, at the National Press Club in Washington, DC. The press club event will be webcast live at: http://www.visualwebcaster.com/hepatitisplan
This Viral Hepatitis Action Plan—which was developed by an interagency working group in collaboration with professional societies, community-based organizations, and other members of the public—was created to address gaps in current viral hepatitis efforts as identified by the Institute of Medicine in its 2010 report on viral hepatitis and liver cancer. To facilitate significant progress in preventing and controlling viral hepatitis, the Viral Hepatitis Action Plan outlines specific goals, strategies, and actions to be undertaken by designated HHS agencies within a defined period of time. Partners also will continue to be engaged as the plan is implemented.
Successfully combating the silent epidemic of viral hepatitis will require collective action. CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) works to integrate prevention opportunities, as persons at risk of acquiring hepatitis are often at risk of acquiring other NCHHSTP focus diseases. This type of collaboration is particularly important for viral hepatitis prevention; several of the populations hardest hit by viral hepatitis are also disproportionately affected by HIV—presenting multiple opportunities for integrating proven interventions. Together, we can take critical, concrete steps towards preventing viral hepatitis infections and improving the health of millions of infected Americans.
To learn more about the Viral Hepatitis Action Plan or Hepatitis Awareness Month, visit the Viral Hepatitis Web site and follow CDC's viral hepatitis Twitter account @CDChep.
This Viral Hepatitis Action Plan—which was developed by an interagency working group in collaboration with professional societies, community-based organizations, and other members of the public—was created to address gaps in current viral hepatitis efforts as identified by the Institute of Medicine in its 2010 report on viral hepatitis and liver cancer. To facilitate significant progress in preventing and controlling viral hepatitis, the Viral Hepatitis Action Plan outlines specific goals, strategies, and actions to be undertaken by designated HHS agencies within a defined period of time. Partners also will continue to be engaged as the plan is implemented.
Successfully combating the silent epidemic of viral hepatitis will require collective action. CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) works to integrate prevention opportunities, as persons at risk of acquiring hepatitis are often at risk of acquiring other NCHHSTP focus diseases. This type of collaboration is particularly important for viral hepatitis prevention; several of the populations hardest hit by viral hepatitis are also disproportionately affected by HIV—presenting multiple opportunities for integrating proven interventions. Together, we can take critical, concrete steps towards preventing viral hepatitis infections and improving the health of millions of infected Americans.
To learn more about the Viral Hepatitis Action Plan or Hepatitis Awareness Month, visit the Viral Hepatitis Web site and follow CDC's viral hepatitis Twitter account @CDChep.
Monday, May 9, 2011
My Birthday Wish (63 this year and holding - about 40+ years with the dragon!)
My Birthday Wish (63 this year and holding - about 40+ years with the dragon!)
Bulletin from the cause: Hepatitis Education Awareness and Liver Support
Go to Cause on Facebook http://www.causes.com/causes/192539
Posted By: PS Pam
To: Members in Hepatitis Education Awareness and Liver Support
My Birthday Wish (63 this year and holding - about 40+ years with the dragon!)
Hello, and thanks for checking out my Birthday Wish!
For my birthday on May 22nd, I'm asking my friends and family for a special gift: help me raise $1000 for Hepatitis Education Awareness and Liver Support. It's a great cause that educates, supports and advocates for Hepatitis - especially Hepatitis C!
I chose Hepatitis Education Awareness and Liver Support because we need help to educate and advocate wherever and whenever we can!
Please consider giving to my Birthday Wish, and together we can destigmatize Hep C, educate the general public about Hep C and why it is so important to get tested and seek medical advice for possible treatment! If you can't give now, I'd really appreciate if you'd share this page with your friends.
Thanks so much,
PSPam
http://www.HEALSoftheSouth.org has a PayPal button or http://www.causes.com/causes/192539
Call to Action
Fundraising Project: H E A L S OF THE SOUTH INC
Donate
Bulletin from the cause: Hepatitis Education Awareness and Liver Support
Go to Cause on Facebook http://www.causes.com/causes/192539
Posted By: PS Pam
To: Members in Hepatitis Education Awareness and Liver Support
My Birthday Wish (63 this year and holding - about 40+ years with the dragon!)
Hello, and thanks for checking out my Birthday Wish!
For my birthday on May 22nd, I'm asking my friends and family for a special gift: help me raise $1000 for Hepatitis Education Awareness and Liver Support. It's a great cause that educates, supports and advocates for Hepatitis - especially Hepatitis C!
I chose Hepatitis Education Awareness and Liver Support because we need help to educate and advocate wherever and whenever we can!
Please consider giving to my Birthday Wish, and together we can destigmatize Hep C, educate the general public about Hep C and why it is so important to get tested and seek medical advice for possible treatment! If you can't give now, I'd really appreciate if you'd share this page with your friends.
Thanks so much,
PSPam
http://www.HEALSoftheSouth.org has a PayPal button or http://www.causes.com/causes/192539
Call to Action
Fundraising Project: H E A L S OF THE SOUTH INC
Donate
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